Food

FDA Issues Interim Final Rule on Record Access Requirements for Food Firms

CFSAN Constituent Update

February 23, 2012

The U.S. Food and Drug Administration (FDA) has issued an interim final rule amending its regulations on record-keeping by food firms to be consistent with FDA's access to records. FDA's authority for access to records was expanded by the FDA Food Safety Modernization Act (FSMA) on January 4, 2011.

The new interim final rule makes the reference to records access in the food-firm record-keeping requirements under FSMA consistent with the current statutory language in the Federal Food, Drug, and Cosmetic Act. FDA's records access and the record-keeping requirements were first established by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

The interim final rule also allows FDA access to records beyond those relating to specific suspect food articles if the agency reasonably believes that the other products are likely to be affected in a similar manner.

This new interim final rule is FDA’s latest step in implementing the FSMA. The expanded records-access authority is expected to improve FDA’s ability to respond to and contain safety problems with the human and animal food supply.

The new interim final rule is effective March 1, 2012. Public comments on the interim final rule may be submitted electronically to the docket through http://www.regulations.gov. In addition, public comments to the guidance mentioned above may also be submitted electronically to http://www.regulations.gov.

All comments on the IFR must include the docket number, FDA-2002-N-0153. All comments to the guidance documents must include the docket number listed in the appropriate Notice of Availability published in the Federal Register.